An Herbal Medicine, Yukgunja‐Tang is more Effective in a Type of Functional Dyspepsia Categorized by Facial Shape Diagnosis: A Placebo‐Controlled, Double‐Blind, Randomized Trial

Abstract

Introduction Functional dyspepsia (FD) is a functional gastrointestinal disorder characterized by persistent upper dyspeptic symptoms without organic lesions. There is no standard therapy for FD. Yukgunja-tang (YGJT) is an herbal medicine used for treating upper gastrointestinal symptoms in Asia. Studies on the effect of YGJT on FD have been conducted. However, the results were inconsistent. In Hyungsang medicine, traditional Korean medicine, FD patients are classified into bladder body (BB) or gallbladder body (GB) subtypes by the shape and angle of their faces. Each subtype may have different characteristics, physiology, and pathology of the same disease. YGJT is more effective for patients with BB subtype. The three-dimensional facial shape diagnostic system (3-FSDS) was shown to be effective in diagnosing BB or GB subtypes. This study aimed to investigate the effect of YGJT on FD patients classified using the 3-FSDS. Materials and Methods The current study was a placebo-controlled, double-blinded, randomized, two-center trial. Eligible patients were diagnosed with either BB or GB FD subtype using the 3-FSDS. Ninety-six participants (48 BB and 48 GB subtypes) were randomly allocated to treatment or control groups in a 2:1 ratio. YGJT or placebo was administered for eight weeks. The primary outcome was assessed using the total dyspepsia symptom scale (TDS), while the secondary outcomes were assessed using the single dyspepsia symptom scale (SDS), proportion of responders, visual analog scale, Nepean dyspepsia index, functional dyspepsia-related quality of life, and spleen qi deficiency questionnaire. Results and Discussion The result of TDS showed the superior effect of YGJT on BB over GB subtype. The subgroup analysis of TDS and SDS scores showed the superior effect of YGJT over placebo. Other outcome variables did not show any significant differences between groups. Conclusion YGJT may be considered for FD patients diagnosed with BB subtype using 3-FSDS.

Efficacy of herbal treatments for functional dyspepsia: A systematic review and meta‐analysis of randomized clinical trials

“…Choi et al, 2015; Y. Choi, Kim, Noh, Lee, & Lee, 2020; Dabos et al, 2010; Du, Ming, Chen, & Li, 2014; Eftekharafzali, Zahedi, Mehrabani, Ahmadi, & Tajadini, 2018; Fani et al, 2010; Ghoshegir et al, 2015; Giacosa et al, 2015; Holtmann et al, 2003; Jung et al, 2016; Khonche, Huseini, Mohtashami, Nabati, & Kianbakht, 2017; J. B. Kim et al, 2014; Ko et al, 2018; Li, Yang, & Li, 2013; Lin, Cai, & Xu, 1998; Liu, Piao, & Guo, 2013; Lv et al, 2017; Madisch, Heydenreich, Wieland, Hufnagel, & Hotz, 1999; Madisch, Holtmann, Mayr, Vinson, & Hotz, 2004; Mala, Thomas, Syam, Maliakel, & Krishnakumar, 2018; Masuy et al, 2020; May, Köhler, & Schneider, 2000; Mohtashami et al, 2015; C. H. Park, Kim, & Lee, 2014; J.‐W. Park et al, 2013; Pasalar et al, 2015a, 2015b; Rafieian‐Kopaei & Hosseini‐Asl, 2015; Raveendra et al, 2012; Rich et al, 2017; Ritter, Schatton, Gessner, & Willems, 1993; Rösch, Vinson, & Sassin, 2002; Su et al, 2018; Suzuki et al, 2014; Tatsuta & Iishi, 1993; Tominaga et al, 2018; Von Arnim, Peitz, Vinson, Gundermann, & Malfertheiner, 2007; Wang, Chen, & Jiang, 2017; Wen et al, 2020; Xiao et al, 2019; Zhang et al, 2013; Zhao & Gan, 2005; L. Zhao et al, 2013) were entered into meta‐analysis.…”

Efficacy and safety of the herbal formula Naesohwajung-tang for functional dyspepsia: a randomized, double-blind, placebo-controlled, multi-center trial

“…The overall score was calculated by adding points for each item, with higher scores indicating more severe indigestion symptoms. The TDS questionnaire has been used as the primary outcome measure in several clinical trials on FD (Zhang et al, 2013;Ko et al, 2018). It was evaluated throughout the 4 weeks study period, including at follow-up visits.…”

<italic>Yukgunja-tang</italic> for Irritable Bowel Syndrome: A Protocol for a Systematic Review and Meta-Analysis

“…YGT consists of Atractylodis lanceae rhizoma (5.63 g), Ginseng radix (3.75 g), Pinellia tubers (5.63 g), Poria cocos (3.75 g), Zizyphi fructus (3.75 g), Aurantii nobilis pericarpium (3.75 g), Glycyrrhizae radix (1.88 g), and Zingiberis rhizoma (3.75 g). Several studies using YGT reported the positive effect on functional gastrointestinal diseases 8,10 , however, there are still lack of studies on the use of YGT for IBS.…”